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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_678 | Other Identifier | Merck | |
| 2009-015563-13 | EudraCT Number |
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This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo |
|
| 600 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo |
|
| 800 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo |
|
| 400 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo |
|
| 600 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo |
|
| 800 mg Grazoprevir - GT3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir | Drug | 10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical and Laboratory Adverse Events (AEs) | An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE. | All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7 | Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr. | Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29703432 | Result | Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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One of the originally planned treatment groups (50 mg Grazoprevir - GT3) was not conducted because other results indicated that further evaluation of 50 mg Grazoprevir in GT3 participants was not necessary. It is therefore not included in the Participant Flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG001 | 600 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG002 | 800 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG003 | 400 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG004 | 600 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG005 | 800 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG006 | 200 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG007 | 100 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG008 | 50 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG009 | 200 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG010 | 100 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG011 | 30 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG012 | 10 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days |
| FG013 | Placebo for Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 400 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG001 | 600 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical and Laboratory Adverse Events (AEs) | An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE. | All participants who received at least one dose of the investigational drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment were combined for the summary into a single GT1 and GT3 arm. | Posted | Number | Participants | All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days) |
|
All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)
All participants who received at least one dose of drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment are combined into a single GT1 and GT3 arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 400 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C578009 | grazoprevir |
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GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo |
|
| 200 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo |
|
| 100 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo |
|
| 50 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo |
|
| 200 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo |
|
| 100 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo |
|
| 50 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo |
|
| 30 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo |
|
| 10 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo |
|
| Placebo | Drug | Placebo tablet, orally, once a day for 7 days |
|
| 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 | Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM. | Day 7 at 24 hours post-dose |
| Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo | Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL. | Baseline and up to approximately 2 months |
| Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo | Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA. | Baseline and up to approximately 2 months |
| Protocol Violation |
|
| BG002 | 800 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG003 | 400 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG004 | 600 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG005 | 800 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG006 | 200 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG007 | 100 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG008 | 50 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG009 | 200 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG010 | 100 mg Grazoprevir - GT3 | GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG011 | 30 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG012 | 10 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days |
| BG013 | Placebo for Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days |
| BG014 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
| OG001 | 600 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days |
| OG002 | 800 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days |
| OG003 | 200 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days |
| OG004 | 100 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days |
| OG005 | 50 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days |
| OG006 | 30 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days |
| OG007 | 10 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days |
| OG008 | Placebo for Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days |
|
|
| Secondary | Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7 | Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr. | Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir. | Posted | Geometric Mean | 90% Confidence Interval | uM.hr | Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose |
|
|
|
| Secondary | 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 | Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM. | Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir. | Posted | Geometric Mean | 90% Confidence Interval | nM | Day 7 at 24 hours post-dose |
|
|
|
| Secondary | Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo | Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL. | Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT1 participant treated with 50 mg grazoprevir, who discontinued, and all GT3 participants treated with grazoprevir were excluded from analysis. | Posted | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | Baseline and up to approximately 2 months |
|
|
|
|
| Secondary | Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo | Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA. | Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT3 participant treated with 800 mg grazoprevir, who discontinued, and all GT1 participants were excluded from analysis. | Posted | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | Baseline and up to approximately 2 months |
|
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | 600 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | 0 | 10 | 3 | 10 |
| EG002 | 800 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | 0 | 20 | 13 | 20 |
| EG003 | 200 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | 0 | 10 | 4 | 10 |
| EG004 | 100 mg Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | 0 | 10 | 1 | 10 |
| EG005 | 50 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | 0 | 6 | 0 | 6 |
| EG006 | 30 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | 0 | 5 | 3 | 5 |
| EG007 | 10 mg Grazoprevir - GT1 | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | 0 | 5 | 4 | 5 |
| EG008 | Placebo for Grazoprevir - GT1 and GT3 | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days | 0 | 15 | 2 | 15 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Macule | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 |
| LSM Difference |
| 4.68 |
| 2-Sided |
| 90 |
| 4.11 |
| 5.25 |
LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. |
| Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | LSM Difference | 4.87 | 2-Sided | 90 | 4.30 | 5.44 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | LSM Difference | 4.35 | 2-Sided | 90 | 3.78 | 4.92 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | LSM Difference | 5.15 | 2-Sided | 90 | 4.58 | 5.72 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | LSM Difference | 4.76 | 2-Sided | 90 | 4.19 | 5.33 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | LSM Difference | 4.93 | 2-Sided | 90 | 4.36 | 5.50 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | LSM Difference | 5.34 | 2-Sided | 90 | 4.93 | 5.74 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 |
| LSM Difference |
| 2.94 |
| 2-Sided |
| 90 |
| 2.38 |
| 3.49 |
LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. |
| Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | LSM Difference | 3.84 | 2-Sided | 90 | 3.29 | 4.40 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | LSM difference | 4.98 | 2-Sided | 90 | 4.42 | 5.53 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |
| It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | LSM difference | 4.21 | 2-Sided | 90 | 3.60 | 4.81 | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | Superiority or Other |